PHARMACEUTICAL COMPOSITION FOR PROPHYLAXIS AND TREATMENT OF CALCIUM METABOLISM DISORDERS COMPRISING CLODRONATE IN COMBINATION WITH GLYCERYL PALMITOSTEARATE
Kind Code:
A2
Abstract not available for EP1408934
Abstract of corresponding document: WO03004008
The object of the present invention is a pharmaceutical composition for oral use, in the form of hard gelatin capsules, which contains an excipient from the triglyceride class, for example atomized glyceryl palmitostearate, with double role, of lubricant and binder. The composition is used for the treatment and prophylaxis of calcium metabolism disorders, such as bone resorbtion, hypercalcemia and osteoporosis and contains as active ingredient a derivate of bisphosphonic acid, for example disodium clodronate. The active ingredient disodium clodronate tetrahydrate, granulated by fluidized bed method, is released from the preparation in a proportion of at least 75 % during the first 5 minutes and at least 95 % in 30 minutes.
Abstract of corresponding document: WO03004008
The object of the present invention is a pharmaceutical composition for oral use, in the form of hard gelatin capsules, which contains an excipient from the triglyceride class, for example atomized glyceryl palmitostearate, with double role, of lubricant and binder. The composition is used for the treatment and prophylaxis of calcium metabolism disorders, such as bone resorbtion, hypercalcemia and osteoporosis and contains as active ingredient a derivate of bisphosphonic acid, for example disodium clodronate. The active ingredient disodium clodronate tetrahydrate, granulated by fluidized bed method, is released from the preparation in a proportion of at least 75 % during the first 5 minutes and at least 95 % in 30 minutes.
Inventors:
Lazar, Lelia-georgeta (RO)
Dinu, Tincuta (RO)
Stancu, Cornelia (RO)
Badea, Irinel (RO)
Rotaru, Maria (RO)
Draghici, Veronica (RO)
Dinu, Tincuta (RO)
Stancu, Cornelia (RO)
Badea, Irinel (RO)
Rotaru, Maria (RO)
Draghici, Veronica (RO)
Application Number:
EP20020760933
Publication Date:
04/21/2004
Filing Date:
07/02/2002
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Export Citation:
Assignee:
Sindan S. C. S. R. L. (RO)
International Classes:
A61K9/16; A61K9/16; A61K9/48; A61K9/48; A61K31/662; A61K31/663; A61P19/00; A61P19/10; (IPC1-7): A61K9/48; A61K9/16; A61K31/663; A61P19/10
European Classes:
A61K9/48H4; A61K31/663
Other References:
See references of WO 03004008A2